BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAREASSIST BED

    MDR report key: 2901404 · Received December 21, 2012

    Report

    Report Number
    3006697241-2012-00310
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 4, 2012
    Manufacturer
    HILLROM DE MEXICO S DE RL DE CV
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TECH ISOLATED THE ISSUE TO A STUCK HEAD UP KEY ON LEFT CAREGIVER CONTROL. HE REPLACED THE LEFT CAREGIVER MEMBRANE CONTROL TO REPAIR THE BED.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE HEAD OF BED WILL NOT LOWER, BUT WILL LOWER USING CPR. WHEN LOWERING WITH CPR, THE HEAD SECTION WILL UNINTENTIONALLY RISE BACK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREASSIST BED AC-POWERED ADJUSTABLE HOSPITAL BED FNL HILLROM DE MEXICO S DE RL DE CV 1170

    Patients

    Seq Age Sex Outcome Treatment
    1